Clinical trial • Phase II • Gastroenterology

MORF-057 for Moderately to severely active Crohn's disease | Crohn's disease

Phase II trial of MORF-057 for Moderately to severely active Crohn's disease | Crohn's disease.

Overview

Trial Therapeutic Area: Gastroenterology
Trial Disease: Moderately to severely active Crohn's disease | Crohn's disease
Trial Stage: Phase II
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 26-01-2024
First CTIS Authorization Date: 22-05-2024

Trial design

Randomised, placebo for morf-057, capsule (placebo comparator); active arms: morf-057 ir capsule (3 active dose regimens - specific doses not stated in provided documents).-controlled Phase II trial in Germany, Spain, Czechia and others.

Randomised: Yes
Comparator: Placebo for MORF-057, capsule (placebo comparator); active arms: MORF-057 IR Capsule (3 active dose regimens - specific doses not stated in provided documents).
Single Multiple Or Escalation Dose Combined: Yes
Target Sample Size: 186
Trial Duration For Participant: 728

Eligibility

Recruits 186 Vulnerable population selected; participants must be "Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.".

Pregnancy Exclusion: Females who are pregnant or lactating or who are planning on becoming pregnant during the course of the study.
Vulnerable Population: Vulnerable population selected; participants must be "Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol."

Inclusion criteria

{"criterion_text":"- 1. Male or female, 18 to 85 years of age, inclusive, at the time of signing the Informed Consent Form (ICF)."}
{"criterion_text":"- 7. If the participant has been receiving any of the non-prohibited medications for CD listed below, he/she must discontinue use at least 5 half-lives before study Day 1 or must agree to maintain stable doses of these concomitant medications starting from the time specified below until the end of the SFU Period, with the exception of tapering oral corticosteroid dose after completion of the Induction Period. a. Oral 5-aminosalicylates (not exceeding 4.8 g per day): at least 2 weeks prior to Screening ileocolonoscopy; b. Oral corticosteroids (not exceeding prednisone 20 mg/day, budesonide 9 mg/day, beclomethasone dipropionate 5 mg/day, methylprednisolone 24 mg/day, or equivalent): at least 2 weeks prior to Screening ileocolonoscopy; c. 6-Mercaptopurine (any stable dose): at least 4 weeks prior to Screening ileocolonoscopy; d. Azathioprine (any stable dose): at least 4 weeks prior to Screening ileocolonoscopy; e. Methotrexate (any stable dose): at least 4 weeks prior to Screening ileocolonoscopy."}
{"criterion_text":"- 8. In the opinion of the Investigator, the participant can fully participate in all aspects of this clinical study."}
{"criterion_text":"- 10. A participant is eligible to participate if he/she agrees to abide by the guidelines regarding contraception requirements: a. A male participant is eligible to participate if he agrees to the following during the study Treatment Period and for at least 90 days after receiving the last dose of MORF-057: • Agrees to abstain from heterosexual intercourse as his preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR • Agrees to use a male condom, with female partner use of an additional contraceptive method; b. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • Is a woman of non-childbearing potential OR • Is a woman of childbearing potential and agrees to use a contraceptive method that is highly effective with a failure rate of <1% per year together with a barrier method used by her or her male partner during the study Treatment Period and for at least 28 days after receiving the last dose of MORF-057."}
{"criterion_text":"- 9. Has a body mass index (BMI) ≥18.0 at Screening."}
{"criterion_text":"- 11. For the study Treatment Period and at least 90 days after receiving the last dose of MORF-057, male participants must agree not to donate sperm. For the study Treatment Period and at least 28 days after receiving the last dose of MORF-057, female participants must agree not to donate eggs (ova, oocytes)."}
{"criterion_text":"- 12. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol."}
{"criterion_text":"- 2. Participant has had a diagnosis of CD supported by signs/symptoms, endoscopy, and histology for at least 90 days prior to Screening. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the Investigator, must be available."}
{"criterion_text":"- 3. Moderately to severely active CD was confirmed during the Screening Period with the following criteria: a) A CDAI score of 220 to 450 inclusive b) An SES-CD score of ≥6. If disease is isolated to the ileum, the requirement will be an SES-CD score ≥4. c) Additional inflammatory markers hs-CRP>5 mg/L and/or fecal calprotectin >250 µg/g."}
{"criterion_text":"- 4. Average daily stool score ≥4 points and/or an average daily abdominal pain score of ≥2 points."}
{"criterion_text":"- 5. Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments (including corticosteroids, immunosuppressants, and/or advanced therapies for CD) in the opinion of the Investigator: a.\tCorticosteroids b. Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate) c. Advanced therapies for CD (e.g., biologic agents, JAK inhibitors, or applicable investigational products [including blinded study treatments in placebo-controlled trials, however, if participants can document that they received only placebo, they will be considered advanced therapy naïve])."}
{"criterion_text":"- 6. Meets the following washout criteria of prior CD therapy relative to study Day 1: a. TNF-α antagonists: at least 5 half-lives; b. IL-12/IL-23 antagonists, including ustekinumab: at least 5 half-lives; c. IL-23 antagonists, including risankizumab, guselkumab or mirikizumab: as least 5 half-lives; d. JAK inhibitors, including tofacitinib or upadacitinib: at least 1 week."}

Exclusion criteria

{"criterion_text":"- 1. Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC."}
{"criterion_text":"- 18. Has a clinically significant abnormal ECG at Screening, including a QT interval corrected through use of Fridericia’s formula (QTcF) ≥450 ms for males and ≥470 ms for females."}
{"criterion_text":"- 19. Abnormal hematology (hemoglobin level, white blood cell [WBC] count, or platelet count) or coagulation results at Screening, as evidenced by the ranges provided below: a. Hemoglobin level <8.0 g/dL; b. Absolute WBC count <3.0x10^9/L; c. Absolute lymphocyte count <0.5x10^9/L or >5.5x10^9/L; d. Absolute neutrophil count <1.2x10^9/L; e. Platelet count <100x10^9/L or 1000x10^9/L; f. International normalized ratio >1.5."}
{"criterion_text":"- 10. Has positive findings on a Subjective Progressive Multifocal Leukoencephalopathy (PML) Checklist during Screening or prior to the administration of the first dose of study drug on study Day 1."}
{"criterion_text":"- 20. Clinically significant abnormal urinalysis results, as deemed by the Investigator or designee."}
{"criterion_text":"- 21. Abnormal organ function at Screening, as evidenced by the following: a. Alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 × upper limit of normal (ULN) b. Chronic kidney disease stages 4 and 5, defined as having a glomerular filtration rate <30 mL/min/1.73 m^2 as calculated using the Modification of Diet in Renal Disease (MDRD) equation (National Kidney Foundation), receiving dialysis, or being listed for or has received a renal transplant c. Total bilirubin ≥1.5×ULN unless the patient has documented diagnosis of Gilbert’s syndrome and other diseases that can present with hyperbilirubinemia have been ruled out."}
{"criterion_text":"- 22. History of active malignancy in the 5 years preceding study Day 1, except in cases of basal cell skin cancer, squamous cell skin cancer, or other in-situ malignancies that have been excised and resolved and the participant was deemed clear of cancer after appropriate follow-up. Participants with a history of malignancy or those at high risk for malignancy may only be enrolled after a consultation with the Medical Monitor."}
{"criterion_text":"- 11. Has a potentially active bacterial, viral, or parasitic pathogenic enteric infection, including Clostridioides difficile (C. difficile); has hepatitis B or C virus, or human immunodeficiency virus (HIV); had an infection requiring hospitalization or intravenous antimicrobial therapy, or an opportunistic infection within 90 days prior to Screening; had any infection requiring oral antimicrobial therapy within 2 weeks prior to Screening; or has a history of more than 1 episode of herpes zoster or any episode of disseminated herpes zoster infection."}
{"criterion_text":"- 12. Has active tuberculosis (TB), as evidenced by any of the following: a. A diagnostic test for TB performed within 30 days prior to Screening or during the Screening Period that is positive, as defined below: • Two consecutive positive interferon gamma release assay (IGRA) tests or 2 consecutive indeterminate IGRA tests OR • A purified protein derivative (PPD) skin test ≥5 mm b. A chest X-ray or imaging per local guidelines within 90 days prior to Screening where active or latent pulmonary TB cannot be excluded."}
{"criterion_text":"- 2. Crohn’s disease isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement."}
{"criterion_text":"- 3. Extensive bowel resection (>100 cm), and/or more than 3 resections, and/or known diagnosis of short bowel syndrome."}
{"criterion_text":"- 7. Currently requires or is anticipated to require surgical intervention for CD during the study duration."}
{"criterion_text":"- 4. Currently receiving total parenteral nutrition, tube feeding, or a formula diet."}
{"criterion_text":"- 5. Has current evidence of un-resected colonic dysplasia or un-resected adenomatous colonic polyps, stoma, ileostomy, or colostomy at Screening."}
{"criterion_text":"- 6. Has any of the following known complications of CD: • abscess (abdominal or perianal) • impassable fibrotic strictures • symptomatic bowel strictures or obstruction • fulminant colitis • toxic megacolon • intra-abdominal or enterocutaneous fistula."}
{"criterion_text":"- 23. Treatment with cyclosporine, mycophenolate, tacrolimus, thalidomide, or sirolimus within 30 days or 5 half-lives (whichever is shorter) prior to study Day 1."}
{"criterion_text":"- 24. Will require treatment with nonsteroidal anti-inflammatory drugs, including but not limited to ibuprofen, naproxen, indomethacin, and celecoxib, during the study. (However, participants may take aspirin for cardio-protection at a dose indicated per local guidelines but not exceeding 325 mg per day.)"}
{"criterion_text":"- 25. Any previous treatment with vedolizumab or other licensed or investigational integrin pathway inhibitors."}
{"criterion_text":"- 26. Experiencing toxicities from prior therapy with Grade >1 within 1 week prior to first dose of study drug."}
{"criterion_text":"- 27. Fecal microbiota transplantation within 90 days prior to Screening."}
{"criterion_text":"- 28. Participant needs to continue treatment with a moderate-to-strong CYP3A inducer or inhibitor and, therefore, will be unable to do a washout period of at least 14 days or 5 half-lives (whichever is longer) prior to study Day 1."}
{"criterion_text":"- 29. Participant needs to continue treatment with an organic anion transporter polypeptide-1B (OATP1B) inhibitor, a P-gp inhibitor, or a narrow therapeutic substrate for P-gp or BCRP, and, therefore, will be unable to do a washout period of at least 14 days or 5 half-lives (whichever is longer) prior to study Day 1."}
{"criterion_text":"- 8. Has had a surgical procedure requiring general anesthesia within 30 days prior to Screening or is planning to undergo major surgery during the study period."}
{"criterion_text":"- 30. Concurrent participation in any other interventional study."}
{"criterion_text":"- 31. Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to study Day 1."}
{"criterion_text":"- 32. Known allergies/hypersensitivity to any component of the study drug."}
{"criterion_text":"- 33. Previous exposure to MORF-057."}
{"criterion_text":"- 34. Females who are pregnant or lactating or who are planning on becoming pregnant during the course of the study."}
{"criterion_text":"- 35. Current or recent history of alcohol dependence or illicit drug use that may interfere with the participant’s ability to comply with the study procedures."}
{"criterion_text":"- 36. Mental or legal incapacitation or a history of clinically significant psychiatric disorders at the time of the Screening Visit that would impact the ability to participate in the trial according to the Investigator."}
{"criterion_text":"- 37. Unable to attend study visits or comply with procedures."}
{"criterion_text":"- 9. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease."}
{"criterion_text":"- 13. Had any vaccination (including live virus vaccinations) within 3 weeks prior to study Day 1."}
{"criterion_text":"- 14. Has a concurrent, clinically significant, serious, unstable comorbidity (such as uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder) that, in the judgement of the Investigator, in consultation with the Sponsor Medical Monitor, would compromise compliance with the protocol, interfere with interpretation of the study results, or pre-dispose participants to safety risks."}
{"criterion_text":"- 15. Has a known primary or secondary immunodeficiency."}
{"criterion_text":"- 16. Has a history of myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure requiring hospitalization, congestive heart failure (New York Heart Association Class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, uncontrolled hypertension, or uncontrolled diabetes within 6 months of Screening."}
{"criterion_text":"- 17. Has a known history of left ventricular ejection fraction (LVEF) <50%."}

Endpoints

Primary endpoints

{"endpoint_text":"- Primary efficacy: Proportion of participants with endoscopic response as determined using the Simple Endoscopic Score-CD (SES-CD) at Week 14.","definition_or_measurement_approach":"Endoscopic response determined using the Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 14; endpoint is the proportion of participants meeting SES-CD based response criteria at Week 14."}

Secondary endpoints

{"endpoint_text":"- Secondary efficacy: - Proportion of participants with clinical response as determined using the CDAI at Week 14; - Proportion of participants with clinical remission as determined using the CDAI at Week 14.","definition_or_measurement_approach":"Clinical response and clinical remission assessed using the Crohn’s Disease Activity Index (CDAI) at Week 14."}
{"endpoint_text":"- Safety: Frequencies and proportions of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation. Change in laboratory parameters, vital signs, and ECG results.","definition_or_measurement_approach":"Safety assessed by frequencies/proportions of TEAEs, TESAEs, and TEAEs leading to discontinuation; monitoring of laboratory parameters, vital signs and ECG changes."}

Recruitment

Registry Or Advocacy Recruitment: True, Asociatia Oncohelp
Planned Sample Size: 186
Recruitment Window Months: 72
Consent Approach: Participants must be capable of giving signed informed consent: "Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol." Informed consent documents (ICFs/SIS) are provided in multiple country/language-specific versions (examples in repository: EN, FR, HU, IT, PL, RO, SK, ES, DE, CZ, LV, HR, RU as available) and site-specific ICFs are used per country. No pediatric assent (minimum age 18).

Geography

Total Number Of Sites: 78
Total Number Of Participants: 199

Germany

Earliest CTIS Part Ii Submission Date: 02-05-2024
Latest Decision Or Authorization Date: 25-03-2026
Processing Time Days: 692
Number Of Sites: 8
Number Of Participants: 16

Sites

Site Name: Martin-Luther-Universitaet Halle-Wittenberg
Department Name: Clinic for Internal Medicine I
Principal Investigator Name: Jens Walldorf
Principal Investigator Email: jens.walldorf@uk-halle.de
Contact Person Name: Jens Walldorf
Contact Person Email: jens.walldorf@uk-halle.de

Site Name: Universitaetsklinikum Schleswig-Holstein AöR
Department Name: Department of Internal Medicine I - Gastroenterology, Hepatology, Nutrition and Geriatrics
Principal Investigator Name: Stefan Schreiber
Principal Investigator Email: stefan.schreiber@uksh.de
Contact Person Name: Stefan Schreiber
Contact Person Email: stefan.schreiber@uksh.de

Site Name: DRK Kliniken Berlin
Department Name: Clinic for Internal Medicine - Gastroenterology, Hematology and Oncology, Nephrology
Principal Investigator Name: Benjamin Moser
Principal Investigator Email: b.moser@drk-kliniken-berlin.de
Contact Person Name: Benjamin Moser
Contact Person Email: b.moser@drk-kliniken-berlin.de

Site Name: Charite Universitaetsmedizin Berlin KöR
Department Name: Medical Clinic for Hepatology and Gastroenterology
Principal Investigator Name: Christoph Jochum
Principal Investigator Email: christoph.jochum@charite.de
Contact Person Name: Christoph Jochum
Contact Person Email: christoph.jochum@charite.de

Site Name: MVZ Dachau
Principal Investigator Name: Wilfred Landry
Principal Investigator Email: landry@dachau-med.de
Contact Person Name: Wilfred Landry
Contact Person Email: landry@dachau-med.de

Site Name: MVZ fuer spezialaerztliche Versorgung Professor Dr. Friedrichs GmbH
Department Name: Gastroenterology
Principal Investigator Name: Wolfgang Nitz
Principal Investigator Email: wolfgang.nitz@sana.de
Contact Person Name: Wolfgang Nitz
Contact Person Email: wolfgang.nitz@sana.de

Site Name: Studiengesellschaft Jakobeit UG
Principal Investigator Name: Christian Jakobeit
Principal Investigator Email: cj@gp-jakobeit.de
Contact Person Name: Christian Jakobeit
Contact Person Email: cj@gp-jakobeit.de

Site Name: Universitaetsklinikum Heidelberg AöR
Department Name: Department of Internal Medicine IV - Gastroenterology, Infectious diseases, Poisoning
Principal Investigator Name: Annika Gauss
Principal Investigator Email: Annika.Gauss@med.uni-heidelberg.de
Contact Person Name: Annika Gauss
Contact Person Email: Annika.Gauss@med.uni-heidelberg.de

Spain

Earliest CTIS Part Ii Submission Date: 23-04-2024
Latest Decision Or Authorization Date: 26-03-2026
Processing Time Days: 702
Number Of Sites: 6
Number Of Participants: 6

Sites

Site Name: Hospital Universitario La Paz
Department Name: Gastroenterology
Principal Investigator Name: María Dolores Martín Arranz
Principal Investigator Email: martinarranz.lapaz@gmail.com
Contact Person Name: María Dolores Martín Arranz
Contact Person Email: martinarranz.lapaz@gmail.com

Site Name: Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name: Gastroenterology
Principal Investigator Name: Xavier Molero
Principal Investigator Email: xmolero@gss.cat
Contact Person Name: Xavier Molero
Contact Person Email: xmolero@gss.cat

Site Name: Hospital Universitario Puerta De Hierro De Majadahonda
Department Name: Gastroenterology
Principal Investigator Name: Irene González Partida
Principal Investigator Email: irenegonzalezpartida@gmail.com
Contact Person Name: Irene González Partida
Contact Person Email: irenegonzalezpartida@gmail.com

Site Name: Area Sanitaria De Ferrol
Department Name: Gastroenterology
Principal Investigator Name: Ana Isabel Echarri Piudo
Principal Investigator Email: ana.echarri.piudo@sergas.es
Contact Person Name: Ana Isabel Echarri Piudo
Contact Person Email: ana.echarri.piudo@sergas.es

Site Name: Hospital Universitario Y Politecnico La Fe
Department Name: Gastroenterology
Principal Investigator Name: María Isabel Iborra Colomino
Principal Investigator Email: marisaiborra@hotmail.com
Contact Person Name: María Isabel Iborra Colomino
Contact Person Email: marisaiborra@hotmail.com

Site Name: Hospital Universitario Virgen De La Macarena
Department Name: Gastroenterology
Principal Investigator Name: Federico Argüelles Arias
Principal Investigator Email: farguelles1@us.es
Contact Person Name: Federico Argüelles Arias
Contact Person Email: farguelles1@us.es

Czechia

Earliest CTIS Part Ii Submission Date: 23-04-2024
Latest Decision Or Authorization Date: 25-03-2026
Processing Time Days: 701
Number Of Sites: 4
Number Of Participants: 27

Sites

Site Name: SurGal Clinic s.r.o.
Department Name: Chirurgické oddělení
Principal Investigator Name: Jan Ulbrych
Principal Investigator Email: ulbrych.jan@surgalclinic.cz
Contact Person Name: Jan Ulbrych
Contact Person Email: ulbrych.jan@surgalclinic.cz

Site Name: Clinoxus s.r.o.
Department Name: Interní ambulance
Principal Investigator Name: Petr Hrabák
Principal Investigator Email: Petr.Hrabak@vfn.cz
Contact Person Name: Petr Hrabák
Contact Person Email: Petr.Hrabak@vfn.cz

Site Name: Vojenska Nemocnice Brno
Department Name: Interní oddělení
Principal Investigator Name: Peter Hegyi
Principal Investigator Email: ibd@vnbrno.cz
Contact Person Name: Peter Hegyi
Contact Person Email: ibd@vnbrno.cz

Site Name: Axon Clinical s.r.o.
Department Name: Interní ambulance
Principal Investigator Name: Jan Matouš
Principal Investigator Email: martin.wallisch@axon-clinical.com
Contact Person Name: Jan Matouš
Contact Person Email: martin.wallisch@axon-clinical.com

France

Earliest CTIS Part Ii Submission Date: 08-02-2024
Latest Decision Or Authorization Date: 25-03-2026
Processing Time Days: 776
Number Of Sites: 3
Number Of Participants: 3

Sites

Site Name: Hospices Civils De Lyon
Department Name: Gastroenterology
Principal Investigator Name: Stephane Nancey
Principal Investigator Email: stephane.nancey@chu-lyon.fr
Contact Person Name: Stephane Nancey
Contact Person Email: stephane.nancey@chu-lyon.fr

Site Name: Centre Hospitalier Universitaire De Saint Etienne
Department Name: Gastroenterology
Principal Investigator Name: Xavier Roblin
Principal Investigator Email: xavier.roblin@chu-st-etienne.fr
Contact Person Name: Xavier Roblin
Contact Person Email: xavier.roblin@chu-st-etienne.fr

Site Name: CHRU De Nancy
Department Name: Gastroenterology
Principal Investigator Name: Marine Ferry
Principal Investigator Email: m.ferry@chru-nancy.fr
Contact Person Name: Marine Ferry
Contact Person Email: m.ferry@chru-nancy.fr

Croatia

Earliest CTIS Part Ii Submission Date: 30-04-2024
Latest Decision Or Authorization Date: 30-03-2026
Processing Time Days: 699
Number Of Sites: 5
Number Of Participants: 6

Sites

Site Name: Zadar General Hospital
Department Name: Gastroenterology
Principal Investigator Name: Ivo Klarin
Principal Investigator Email: ivo.klarin@zd.t-com.hr
Contact Person Name: Ivo Klarin
Contact Person Email: ivo.klarin@zd.t-com.hr

Site Name: Specijalna Bolnica Medico
Department Name: Gastroenterology
Principal Investigator Name: Davor Stimac
Principal Investigator Email: davor.stimac7@gmail.com
Contact Person Name: Davor Stimac
Contact Person Email: davor.stimac7@gmail.com

Site Name: Poliklinika Solmed d.o.o.
Department Name: Gastroenterology
Principal Investigator Name: Dominik Kralj
Principal Investigator Email: dominik.rex@gmail.com
Contact Person Name: Dominik Kralj
Contact Person Email: dominik.rex@gmail.com

Site Name: Opca Bolnica Virovitica
Department Name: Gastroenterology
Principal Investigator Name: Matko Markotic
Principal Investigator Email: matkomarkotic@gmail.com
Contact Person Name: Matko Markotic
Contact Person Email: matkomarkotic@gmail.com

Site Name: Poliklinika Borzan d.o.o.
Department Name: Gastroenterology
Principal Investigator Name: Vladimir Borzan
Principal Investigator Email: study@poliklinika-borzan.hr
Contact Person Name: Vladimir Borzan
Contact Person Email: study@poliklinika-borzan.hr

Latvia

Earliest CTIS Part Ii Submission Date: 22-04-2024
Latest Decision Or Authorization Date: 25-03-2026
Processing Time Days: 702
Number Of Sites: 2
Number Of Participants: 4

Sites

Site Name: Pauls Stradins Clinical University Hospital
Department Name: Center of Gastroenterology, Hepatology and Nutrition
Principal Investigator Name: Aldis Pukitis
Principal Investigator Email: pukltls@latnet.lv
Contact Person Name: Aldis Pukitis
Contact Person Email: pukltls@latnet.lv

Site Name: Liepajas Regionala Slimnica SIA
Department Name: Gastroenterology Department
Principal Investigator Name: Linda Erne
Principal Investigator Email: liepaajaa@inbox.lv
Contact Person Name: Linda Erne
Contact Person Email: liepaajaa@inbox.lv

Hungary

Earliest CTIS Part Ii Submission Date: 18-03-2024
Latest Decision Or Authorization Date: 27-03-2026
Processing Time Days: 739
Number Of Sites: 6
Number Of Participants: 15

Sites

Site Name: Semmelweis University
Department Name: Department of Internal Medicine and Oncology
Principal Investigator Name: Akos Ilias
Principal Investigator Email: titkarsag.bel1@semmelweis.hu
Contact Person Name: Akos Ilias
Contact Person Email: titkarsag.bel1@semmelweis.hu

Site Name: Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name: Department of Internal Medicine - Gastroenterology
Principal Investigator Name: Zoltan Sallo
Principal Investigator Email: titkar@mfkh.hu
Contact Person Name: Zoltan Sallo
Contact Person Email: titkar@mfkh.hu

Site Name: Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name: Department of Internal Medicine I
Principal Investigator Name: Roland Fejes
Principal Investigator Email: rfejes@mail.fmkorhaz.hu
Contact Person Name: Roland Fejes
Contact Person Email: rfejes@mail.fmkorhaz.hu

Site Name: Gyongyosi Bugat Pal Korhaz
Department Name: Department of Gastroenterology
Principal Investigator Name: Gabor Makai
Principal Investigator Email: korhaz@bugatpal.hu
Contact Person Name: Gabor Makai
Contact Person Email: korhaz@bugatpal.hu

Site Name: Clinfan Kft.
Department Name: Gastroenterology Outpatient Clinic
Principal Investigator Name: Agnes Salamon
Principal Investigator Email: salamonagidr@gmail.com
Contact Person Name: Agnes Salamon
Contact Person Email: salamonagidr@gmail.com

Site Name: Bekes Varmegyei Koezponti Korhaz
Department Name: Department of Internal Medicine – Gastroenterology - Hepatology
Principal Investigator Name: Marta Varga
Principal Investigator Email: gasztrobcs@bmkk.eu
Contact Person Name: Marta Varga
Contact Person Email: gasztrobcs@bmkk.eu

Italy

Earliest CTIS Part Ii Submission Date: 22-03-2024
Latest Decision Or Authorization Date: 27-03-2026
Processing Time Days: 735
Number Of Sites: 8
Number Of Participants: 15

Sites

Site Name: Humanitas Research Hospital
Department Name: Biomedical Sciences
Principal Investigator Name: Alessandro Armuzzi
Principal Investigator Email: alessandro.armuzzi@unimed.eu
Contact Person Name: Alessandro Armuzzi
Contact Person Email: alessandro.armuzzi@unimed.eu

Site Name: Casa Sollievo Della Sofferenza
Department Name: UOC Gastroenterology and digestive endoscopy
Principal Investigator Name: Fabrizio Bossa
Principal Investigator Email: f.bossa@operapadrepio.it
Contact Person Name: Fabrizio Bossa
Contact Person Email: f.bossa@operapadrepio.it

Site Name: Ospedale San Raffaele S.r.l.
Department Name: Gastroenterology and Endoscopic Unit
Principal Investigator Name: Silvio Danese
Principal Investigator Email: danese.silvio@hsr.it
Contact Person Name: Silvio Danese
Contact Person Email: danese.silvio@hsr.it

Site Name: IRCCS Policlinico San Donato
Department Name: Gastroenterology
Principal Investigator Name: Vito Annese
Principal Investigator Email: vito.annese@grupposandonato.it
Contact Person Name: Vito Annese
Contact Person Email: vito.annese@grupposandonato.it

Site Name: Azienda Ospedaliera Ospedale Niguarda Ca Granda
Department Name: Medico Polispecialistico
Principal Investigator Name: Marcello Vangeli
Principal Investigator Email: marcello.vangeli@ospedaleniguarda.it
Contact Person Name: Marcello Vangeli
Contact Person Email: marcello.vangeli@ospedaleniguarda.it

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name: Gastroenterology and digestive Endoscopy
Principal Investigator Name: Fernardo Rizzello
Principal Investigator Email: fernando.rizzello@unibo.it
Contact Person Name: Fernardo Rizzello
Contact Person Email: fernando.rizzello@unibo.it

Site Name: IRCCS Ospedale Sacro Cuore Don Calabria
Department Name: Gastroenterology
Principal Investigator Name: Angela Variola
Principal Investigator Email: angela.variola@sacrocuore.it
Contact Person Name: Angela Variola
Contact Person Email: angela.variola@sacrocuore.it

Site Name: San Camillo Forlanini Hospital
Department Name: Department of Gastroenterology
Principal Investigator Name: Rocco Cosintino
Principal Investigator Email: rcosintino@sancamilloforlanini.rm.it
Contact Person Name: Rocco Cosintino
Contact Person Email: rcosintino@sancamilloforlanini.rm.it

Austria

Earliest CTIS Part Ii Submission Date: 22-04-2024
Latest Decision Or Authorization Date: 27-03-2026
Processing Time Days: 704
Number Of Sites: 4
Number Of Participants: 4

Sites

Site Name: Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name: Department of Internal Medicine I
Principal Investigator Name: Sonja Heeren
Principal Investigator Email: s.heeren@salk.at
Contact Person Name: Sonja Heeren
Contact Person Email: s.heeren@salk.at

Site Name: Noe LGA Gesundheit Region Mitte GmbH
Department Name: Univ. Hospital St. Poelten, Dep. of Internal Medicine II, Div. of Gastroenterology and Hepatology
Principal Investigator Name: Andreas Maieron
Principal Investigator Email: andreas.maieron@stpoelten.lknoe.at
Contact Person Name: Andreas Maieron
Contact Person Email: andreas.maieron@stpoelten.lknoe.at

Site Name: Medical University Of Vienna
Department Name: Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Principal Investigator Name: Walter Reinisch
Principal Investigator Email: walter.reinisch@meduniwien.ac.at
Contact Person Name: Walter Reinisch
Contact Person Email: walter.reinisch@meduniwien.ac.at

Site Name: Medizinische Universitaet Innsbruck
Department Name: University Hospital for Internal Medicine I
Principal Investigator Name: Robert Koch
Principal Investigator Email: robert.koch@i-med.ac.at
Contact Person Name: Robert Koch
Contact Person Email: robert.koch@i-med.ac.at

Poland

Earliest CTIS Part Ii Submission Date: 07-05-2024
Latest Decision Or Authorization Date: 27-03-2026
Processing Time Days: 689
Number Of Sites: 24
Number Of Participants: 86

Slovakia

Earliest CTIS Part Ii Submission Date: 05-04-2024
Latest Decision Or Authorization Date: 25-03-2026
Processing Time Days: 719
Number Of Sites: 4
Number Of Participants: 7

Sites

Site Name: Gastro LM s.r.o.
Department Name: Gastroenterologická ambulancia
Principal Investigator Name: Ľubomír Mihalkanin
Principal Investigator Email: mihalkanin@gmail.com
Contact Person Name: Ľubomír Mihalkanin
Contact Person Email: mihalkanin@gmail.com

Site Name: Endomed s.r.o.
Department Name: Gastroenterológia
Principal Investigator Name: Miroslav Fedurco
Principal Investigator Email: fedurco@endomed.sk
Contact Person Name: Miroslav Fedurco
Contact Person Email: fedurco@endomed.sk

Site Name: Cliniq s.r.o.
Department Name: Gastroenterológia
Principal Investigator Name: Tibor Hlavatý
Principal Investigator Email: tibor.hlavaty2@gmail.com
Contact Person Name: Tibor Hlavatý
Contact Person Email: tibor.hlavaty2@gmail.com

Site Name: Gastro I. s.r.o.
Department Name: Gastroenterológia
Principal Investigator Name: Bohuš Bunganič
Principal Investigator Email: gastrobunganic@gmail.com
Contact Person Name: Bohuš Bunganič
Contact Person Email: gastrobunganic@gmail.com

Romania

Earliest CTIS Part Ii Submission Date: 08-02-2024
Latest Decision Or Authorization Date: 30-03-2026
Processing Time Days: 781
Number Of Sites: 4
Number Of Participants: 10

Sites

Site Name: Centrul Medical Sfanta Vineri S.R.L.
Department Name: Gastroenterology
Principal Investigator Name: Marieta Madalina Florescu
Principal Investigator Email: asistenta.sfvineri@yahoo.com
Contact Person Name: Marieta Madalina Florescu
Contact Person Email: asistenta.sfvineri@yahoo.com

Site Name: Asociatia Oncohelp
Department Name: Gastroenterology
Principal Investigator Name: Razvan Gheorghe Diaconescu
Principal Investigator Email: office@oncohelp.ro
Contact Person Name: Razvan Gheorghe Diaconescu
Contact Person Email: office@oncohelp.ro

Site Name: Memorial Healthcare International S.R.L.
Department Name: Gastroenterology
Principal Investigator Name: Ion-Eugeniu Craciun
Principal Investigator Email: eugencraciun@yahoo.com
Contact Person Name: Ion-Eugeniu Craciun
Contact Person Email: eugencraciun@yahoo.com

Site Name: Spitalul Clinic Colentina Bucuresti
Department Name: Gastroenterology
Principal Investigator Name: Radu Bogdan Mateescu
Principal Investigator Email: bogmateescu@gmail.com
Contact Person Name: Radu Bogdan Mateescu
Contact Person Email: bogmateescu@gmail.com

Sponsor

Primary sponsor

Full Name: Morphic Therapeutic Inc.
Organisation Type: Pharmaceutical company
Country Of Registered Address: United States

Contract research organisations

Name: Psi Cro AG
Responsibilities: sponsorDuties codes: [1,11,12,13,2,5,9]

Name: 4g Clinical LLC
Responsibilities: sponsorDuties codes: [3]

Name: Medpace Belgium / Medpace Reference Laboratories
Responsibilities: Central laboratory/PK/analysis duties (sponsorDuties codes: [4])

Name: Eclinical Solutions LLC
Responsibilities: eClinical solutions / data (sponsorDuties codes: [6])

Third parties

{"country":"United States","full_name":"Eclinical Solutions LLC","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
{"country":"France","full_name":"Quipment","duties_or_roles":"Clinical Supplies (code 15)","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Eli Lilly & Co.","duties_or_roles":"sponsorDuties codes: [8]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: [14, 15] value: QP Release","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"sponsorDuties codes: [1,11,12,13,2,5,9]","organisation_type":"Pharmaceutical company"}
{"country":"Belgium","full_name":"Medpace Belgium","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"CluePoints INC","duties_or_roles":"sponsorDuties codes: [15] value: Central Monitoring","organisation_type":"Industry"}
{"country":"United States","full_name":"Medpace Bioanalytical Laboratories","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Health care"}
{"country":"United States","full_name":"DeltaMed Solutions, Inc.","duties_or_roles":"sponsorDuties codes: [10]","organisation_type":"Industry"}
{"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
{"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"sponsorDuties codes: [15] value: Central Imaging, Histology","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: MORF-057 IR Capsule
Active Substance: MORF-057
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: Oral
Authorisation Status: Investigational (MIA(IMP) 20377)
Dose Levels: 3 active dose regimens (specific doses not stated in provided documents)
Maximum Dose: 400 mg per day (maxDailyDoseAmount: 400 mg)

Investigational Product Name: Placebo for MORF-057, capsule
Modality: Other
Authorisation Status: Placebo for MORF-057 (investigational comparator)

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